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Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Must have participated in specific Phase 3 parent study

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Failed screening for parent study, pregnant women, lactating mothers

NCT01127893
Pfizer
Terminated
Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis

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Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis
A Phase 3, Multicenter, Randomized, Long Term Study Of The Safety Of The Subcutaneous Administration Of Tanezumab In Patients With Osteoarthritis Of The Knee
An evaluation of the long term safety of tanezumab when administered by subcutaneous injection every 8 weeks for up to 64 weeks
This study was terminated on 29 September 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Osteoarthritis
  • Biological: Tanezumab
    Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for up to 7 injections
  • Biological: Tanezumab
    Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections
  • Biological: Tanezumab
    Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections
  • Experimental: Tanezumab 10 mg
    Intervention: Biological: Tanezumab
  • Experimental: Tanezumab 5 mg
    Intervention: Biological: Tanezumab
  • Experimental: Tanezumab 2.5 mg
    Intervention: Biological: Tanezumab
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
September 2010
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must have participated in specific Phase 3 parent study

Exclusion Criteria:

  • Failed screening for parent study, pregnant women, lactating mothers
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01127893
A4091032
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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